Sungura Study
Efficacy, safety and tolerability of switching to DTG/3TC single tablet regimen from B/F/TAF in older persons living with HIV in Kenya
Study Design
Phase 3b, multi-center, open-label, single arm clinical trial over 96 weeks to assess the efficacy and safety of switching to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in 197 participants ≥60 years.
Primary Endpoint
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48
Study Objectives
- Assess the efficacy of switching from B/F/TAF to DTG/3TC in maintaining viral suppression
- Evaluate the safety and tolerability of DTG/3TC in older adults living with HIV
- Monitor changes in renal and bone biomarkers following the switch
- Assess patient-reported outcomes and quality of life measures
- Evaluate treatment satisfaction and adherence to the new regimen
Eligibility Criteria
Inclusion Criteria
- HIV-1 positive adults aged 60 years or older
- Currently receiving B/F/TAF (bictegravir, emtricitabine and tenofovir alafenamide)
- Virologically suppressed (HIV-1 RNA <50 copies/mL for at least 6 months)
- No documented resistance mutations to study drugs
- Stable on current regimen for at least 3 months
- Able to provide informed consent
Exclusion Criteria
- Known hypersensitivity to dolutegravir or lamivudine
- Active opportunistic infections
- Severe hepatic impairment
- Concurrent use of medications with significant drug interactions
- Pregnant or breastfeeding women
- History of non-adherence to antiretroviral therapy
Study Procedures
Screening visit with comprehensive medical history and physical examination
Laboratory assessments including HIV-1 RNA, CD4+ cell count, and safety parameters
Switch to DTG/3TC single tablet regimen
Regular follow-up visits at weeks 4, 12, 24, 48, 72, and 96
Adverse event monitoring and safety assessments
Patient-reported outcome questionnaires
End-of-study evaluations